OHTUVAYRE Drug Patent Profile

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Which patents cover Ohtuvayre, and what generic alternatives are available?

Ohtuvayre is a drug marketed by Verona Pharma and is included in one NDA. There are three patents protecting this drug.

This drug has eighty-eight patent family members in thirty countries.

The generic ingredient in OHTUVAYRE is ensifentrine. One supplier is listed for this compound. Additional details are available on the ensifentrine profile page.

DrugPatentWatch^® Generic Entry Outlook for Ohtuvayre

Ohtuvayre will be eligible for patent challenges on June 26, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 26, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for OHTUVAYRE

International Patents:	88
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in OHTUVAYRE?	OHTUVAYRE excipients list
DailyMed Link:	OHTUVAYRE at DailyMed

Drug patent expirations by year for OHTUVAYRE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OHTUVAYRE

Generic Entry Date for OHTUVAYRE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: NEW CHEMICAL ENTITY NDA: 217389 Dosage: SUSPENSION;INHALATION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for OHTUVAYRE

OHTUVAYRE is protected by three US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of OHTUVAYRE is ⤷ Sign Up.

This potential generic entry date is based on NEW CHEMICAL ENTITY.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting OHTUVAYRE

Liquid inhalation formulation comprising RPL554
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Crystalline form of pyrimido[6,1-A] isoquinolin-4-one compound
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR THE MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) IN ADULT PATIENTS

Liquid inhalation formulation comprising RPL554
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR THE MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) IN ADULT PATIENTS

FDA Regulatory Exclusivity protecting OHTUVAYRE

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Verona Pharma	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Verona Pharma	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Verona Pharma	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Verona Pharma	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for OHTUVAYRE

See the table below for patents covering OHTUVAYRE around the world.

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2603509	FORME CRYSTALLINE D'UN CONPOSE DE PYRIMIDO[6,1-A] ISOQUINOLIN-4-ON (CRYSTALLINE FORM OF PYRIMIDO[6,1-A] ISOQUINOLIN-4-ONE COMPOUND)	⤷ Sign Up
Japan	2013533301		⤷ Sign Up
Brazil	112013003087	forma cristalina de composto de pirimidio[6,1-a]-isoquinolin-4-ona	⤷ Sign Up
Lithuania	3193835		⤷ Sign Up
Hungary	E055527		⤷ Sign Up
Russian Federation	2699995	ЖИДКАЯ ИНГАЛЯЦИОННАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ RPL 554 (LIQUID INHALATION COMPOSITION CONTAINING RPL554)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration